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FDA 510(k) Application Details - K121122
Device Classification Name
Drug Mixture Control Materials
More FDA Info for this Device
510(K) Number
K121122
Device Name
Drug Mixture Control Materials
Applicant
BIOCHEMICAL DIAGNOSTIC, INC.
180 HEARTLAND BLVD.
Edgewood, NY 11717 US
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Contact
ALLEN PANETZ
Other 510(k) Applications for this Contact
Regulation Number
862.3280
More FDA Info for this Regulation Number
Classification Product Code
DIF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/13/2012
Decision Date
07/03/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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